Job Description
Our client is a niche Regulatory consulting firm which provides the highest-level Regulatory expertise to a variety of biotech and pharmaceutical clients. They are seeking a Regulatory Affairs Advertising & Promotions Principal Consultant who can provide leadership on advertising and promotional materials for various client projects. You will be responsible for the daily management of regulatory requirements for Advertising & Promotions and serve as a subject matter expert. This is a remote role where you will work closely with exciting biopharma clients and collaborate internally with a team of biopharmaceutical leaders and innovators. This company offers a competitive salary, comprehensive employee benefits, and the ability to work from home. Now is an exciting time to join this dynamic and growing organization! Responsibilities: Daily management of regulatory requirements for advertising and promotions for one or more client projects. Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy. Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership. Provide strategic and operational leadership for promotional, educational, and investigative communications Use extensive knowledge of country-specific regulatory requirements (US, EU and ICH) and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support clients' corporate goals. Manage launch preparation of promotional material for one or more products. Provide support and guidance to regulatory teams on RA requirements for one or more drug products. Maintain knowledge of changing regulatory requirements and advise teams as appropriate. Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects. Qualifications: Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred. Must have a minimum of 7 years of experience in pharmaceutical regulatory affairs specializing in Advertising & Promotions. Must have experience reviewing promotional materials across a variety of platforms (print, TV, online, DTC, etc) Prior experience with product launches is required. Experience with Accelerated Approvals highly desired. Experience working directly with OPDP is a must. Experience with APLB is a plus, but not required. Prior experience with payer materials and medical affairs required. Experience across multiple therapeutic areas is a plus, and experience with oncology and/or rare disease areas is highly desired. US experience is required and global/international experience is desired. Must have experience working with Veeva for management of promotional materials. Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections. Ability to work independently and innovatively in tackling operational challenges. Must be collaborative and work well with clients. This is a remote position with some occasional travel for client meetings. The budgeted salary range for this position is $240,000 to $275,000 plus a quarterly bonus program and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.